Facility​/Control Engineer

This is a hybrid position. (3 days in office, 2 days remote). Local candidates only.

• Technical science and/or engineering education.
• Experience in life sciences industry, preferably in pharmaceutical GMP and/or GDP regulated environments.
• Experience with pharmaceutical qualification/validation processes, preferably with shipping, equipment and/or facility qualification/validation.
• Experience writing technical reports and quality system procedures.
• Experience writing, coordinating and executing qualification/validation activities (including validation plans, protocols, summary reports).
• 4‑year college degree; preferably a BS in Chemistry, Biology, Engineering, Pharmacy, or Microbiology.
• Minimum of 4–7 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
• Sound knowledge of current regulatory requirements (21 CFR Part 11, EU GMP Annex 11/15, ICH, PIC/S) and Best Practices (GAMP 5, etc.).
• Proven ability to work in a global environment and on virtual teams.
• Excellent communication capabilities and teamwork capacities.
• Experience providing QA oversight of equipment, facility, utility, instrument qualification and cleaning, automated process controller, qualification and validation.

• Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP‑, GCP‑ and GMP‑regulated areas of an R&D organization.
• Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages with minimal supervision.
• Compile, review, and approve quality documents (policies, processes, procedures, templates, formats, etc.).
• Support CAPA activities related to validation and qualification.
• Provide guidance, direction, and support to peers.